GVOKE VIALDX

AbsorptionSubcutaneous injection of 1 mg GVOKE in adult type 1 diabetes mellitus patients resulted in a mean glucagon C max of 2481.3 pg/mL, t max of 50 minutes and AUC 0‑240min of 3454.6 pg*min/mL.See Figure 3. Figure 3: : Plasma Glucagon Concentration (mean ± standard error of the mean) vs. Time After Subcutaneous Administration of 1 mg of GVOKE in Adults with Type 1 Diabetes Mellitus

DistributionThe apparent volume of distribution was in the range of 137-2425 L.

EliminationThe half-life of...

14.1 Adult Patients with Type 1 Diabetes Mellitus for the Treatment of Severe Hypoglycemia GVOKE was evaluated in adult patients aged 18 to 74 years with type 1 diabetes mellitus in two multi-center 2-way crossover studies: Study A was double-blinded with 80 patients, and Study B was single-blinded with 81 patients. Both studies involved 2 clinic visits 7 to 28 days apart, with random assignment to receive GVOKE 1 mg subcutaneous injection during one session and glucagon 1 mg subcutaneous injection (subcutaneous glucagon) during the other. In these studies, 154 patients received GVOKE and 157 ...

The following serious adverse reactions are described below and elsewhere in labeling: Substantial Increase in Blood Pressure in Patients with Pheochromocytoma [see Warnings and Precautions ( 5.1 )] . Hypoglycemia in Patients with Insulinoma [see Warnings and Precautions ( 5.2 )] . Serious Hypersensitivity Reactions [see Warnings and Precautions (5.3)] Lack of Efficacy With Subcutaneous Use for Severe Hypoglycemia in Patients with Decreased Hepatic Glycogen [see Warnings and Precautions ( 5.4 )]...

GVOKE and GVOKE VialDx are contraindicated in patients with: Pheochromocytoma because of the risk of substantial increase in blood pressure [see Warnings and Precautions ( 5.1 )] Insulinoma because of the risk of hypoglycemia [see Warnings and Precautions ( 5.2 )] Prior hypersensitivity reaction to glucagon or to any of the excipients in GVOKE or GVOKE VialDx. Serious hypersensitivity reactions ha...

Substantial Increase in Blood Pressure in Patients with Pheochromocytoma: Contraindicated in patients with pheochromocytoma because glucagon may stimulate the release of catecholamines from the tumor. ( 5.1 ) Hypoglycemia in Patients with Insulinoma: In patients with insulinoma, administration may produce an initial increase in blood glucose; however, glucagon may stimulate exaggerated insulin release from an insulinoma and cause hypoglycemia. If a patient develops symptoms of hypoglycemia after...

7 DRUG INTERACTIONS

Table 4Clinically Significant Drug Interaction with GVOKE and GVOKE VialDx Beta-Blockers Clincial Impact: Patients taking beta-blockers may have a transient increase in pulse and blood pressure when given GVOKE or GVOKE VialDx. Intervention The increase in blood pressure and heart rate may require therapy in patients with coronary artery disease. Insulin Clincial Impact: Insu...